Comparison of techniques of oral hygiene - a multidisciplinary randomised study on training of oral hygiene skills

Organizational Data

DRKS-ID:
DRKS00003488
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2012-01-20
Last update in DRKS:
2019-08-06
Registration type:
Retrospective

Acronym/abbreviation of the study

MHV_I

URL of the study

No Entry

Brief summary in lay language

The study is conceptualized as experimental basic research. Participants are students outside dentistry. The study compares the effectiveness of computerpresentations aiming to train different oral hygiene techniques. The study tests the hypothesis that a training on a hygiene technique will improve oral hygiene skills and thereby habitual oral hygiene as well which will result in a reduction of gingivitis. Further the study tests the hypothesis that differing hygiene techniques differ with respect to the extent of oral hygiene skills and habitual hygiene achieved.

Brief summary in scientific language

Analyses the effectiveness of differing computerbased trainings to improve oral hygiene skills

Health condition or problem studied

ICD10:
K05.1 - Chronic gingivitis
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Basics of oral hygiene: Sties to be cleaned and by which means they can be reached (toooth brush, tooth floss). Pressure which should be applied while brushing and systematics of tooth brushing.
Arm 2:
Basics of oral hygiene plus modified Bass techniques
Arm 3:
Basics of oral hygiene plus Fones technique

Endpoints

Primary outcome:
Gingivitis; 6,12, 28 weeks after intervention; assessed by the papillary bleeding index
Secondary outcome:
Oral hygiene skills; 6, 12, 28 weeks after intervention; assessed by plaque accumulation after thorough oral hygiene via marginal plaque index and Turesky modification of the Quigley & Hein Index

Study Design

Purpose:
Prevention
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Assessor
  • Investigator/therapist
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Universität Gießen

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2009-11-11
Planned study completion date:
No Entry
Actual Study Completion Date:
2010-09-06
Target Sample Size:
66
Final Sample Size:
67

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
students; at least 10 sites showing papillary bleeding index > 0

Exclusion Criteria

students of dentistry, smoking, less than 20 teeth

Addresses

Primary Sponsor

Address:
Institut für Medizinische Psychologie Fachbereich 11 - Medizin Justus-Liebig-Universität Gießen
Prof. Dr. Renate Deinzer
Friedrichstr. 36
35392 Gießen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Institut für Medizinische Psychologie Fachbereich 11 - Medizin Justus-Liebig-Universität Gießen
Prof. Dr. Renate Deinzer
Friedrichstr. 36
35392 Gießen
Germany
Telephone:
+ 49 641 99 45681
Fax:
+ 49 641 99 45689
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Address:
Institut für Medizinische Psychologie Fachbereich 11 - Medizin Justus-Liebig-Universität Gießen
Prof. Dr. Renate Deinzer
Friedrichstr. 36
35392 Gießen
Germany
Telephone:
+ 49 641 99 45681
Fax:
+49 641 99 45689
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Principal Investigator

Address:
Institut für Medizinische Psychologie Fachbereich 11 - Medizin Justus-Liebig-Universität Gießen
Prof. Dr. Renate Deinzer
Friedrichstr. 36
35392 Gießen
Germany
Telephone:
+ 49 641 99 45681
Fax:
+ 49 641 99 45689
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Address:
GABA International
4106 Therwill
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

Address:
Institut für Medizinische Psychologie Fachbereich 11 - Medizin Justus-Liebig-Universität Gießen
Friedrichstr. 36
35392 Gießen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Address:
Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
Frankfurter Straße 51-53
35392 Gießen
Germany
Telephone:
+49-641-9942470
Fax:
+49-641-9942479
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2009-06-25
Ethics committee number:
91/09
Vote of the Ethics Committee:
Approved
Date of the vote:
2009-07-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Harnacke D, Mitter S, Lehner M, Munzert J, Deinzer R (2012) Improving Oral Hygiene Skills by Computer-Based Training: A Randomized Controlled Comparison of the Modified Bass and the Fones Techniques. PLoS ONE 7(5):e37072. doi:10.1371/journal.pone.0037072
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry